Atellica® IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay

FDA Premarket Approval P100039 S015

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceAtellica® IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantSIEMENS HEALTHCARE DIAGNOSTICS INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP100039 Supplement NumberS015 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-03-22
Decision Date2022-03-29
PMAP100039
SupplementS015
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressSIEMENS HEALTHCARE DIAGNOSTICS INC.
511 Benedict Ave.
tarrytown, NY 10591 PMA NumberP100039 Supplement NumberS015 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM  Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Manufacture An Instrument Component At Another Location

Supplemental Filings

Supplement NumberDateSupplement Type
P100039Original Filing
S015 2022-03-22 30-day Notice
S014 2022-01-20 30-day Notice
S013 2021-04-01 30-day Notice
S012 2021-03-26 30-day Notice
S011 2020-12-22 Real-time Process
S010 2020-07-31 30-day Notice
S009 2020-03-09 30-day Notice
S008 2020-02-21 30-day Notice
S007 2019-02-01 30-day Notice
S006 2018-07-19 Real-time Process
S005 2017-07-14 Normal 180 Day Track
S004 2015-07-13 Normal 180 Day Track
S003 2015-06-11 30-day Notice
S002 2012-09-28 Real-time Process
S001 2012-04-30 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00630414597843 P100039 001
00630414597836 P100039 001
00630414591407 P100039 001
00630414561790 P100039 001
00630414551777 P100039 001
00630414301273 P100039 001
00630414600512 P100039 002
00630414555300 P100039 002

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